A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM

NCT04198480 | Unknown Phase 1

• 1 other identifier: JMT103CN04
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the potential of JMT103 to treat hypercalcemia of malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates.

Conditions

Hypercalcemia of Malignancy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103

  Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103

  10 Days after First Dose of JMT103

Secondary Outcomes (7)

• Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL（2.9 mmol/L） by each visit.

  through study completion, an average of 57 Days

• Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL（2.7 mmol/L） by each visit.

  through study completion, an average of 57 Days

• Time to Response

  through study completion, an average of 57 Days

• Time to Complete Response

  through study completion, an average of 57 Days

• Duration of Response

  through study completion, an average of 57 Days

Study Arms (1)

JMT103

EXPERIMENTAL

Eligible subjects will receive JMT103 at a dose of 2 mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2 mg/kg SC on study days 8 and 15.

Drug: JMT103

Interventions

JMT103 DRUG

2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.

JMT103

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully informed and signed informed consent.
• Male or female, Adults (\>/=18 years).
• Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) \> 12.5 mg/dL (3.1 mmol /L).
• Last IV bisphosphonate treatment must be \>/= 7 days and \</= 30 days before the screening corrected serum calcium; or Last hydration therapy must be \>/= 24 hours before the screening corrected serum calcium（Incompatible bisphosphonate）.
• Adequate organ function.

You may not qualify if:

• Pregnancy.
• Hyperparathyroidism, or other granulomatous disease.
• Hepatitis b surface antigen positive.
• Hepatitis c antibody positive, or HIV antibody positive.
• Receiving dialysis for renal failure.
• Known sensitivity to JMT103 composition.
• Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of screening CSC.
• Treatment with cinacalcet within 4 weeks prior to the date of screening CSC.
• Currently participating another clinical study，or Four weeks or less since receiving an investigational product in another clinical study.
• Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

MeSH Terms

Conditions

Humoral Hypercalcemia Of Malignancy

Study Officials

• Jin LI, PHD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XIUGAO YANG

CONTACT

+86-13811660565; yangxiugao@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 13, 2019
• Study Start: January 24, 2020
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share